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Unique Device Identification Requirements for Convenience Kits

This guidance clarifies FDA's interpretation of convenience kit for the Unique Device Identification (UDI) system requirements. It applies to medical devices packaged together but excludes in vitro diagnostic (IVD) devices and combination products.

  1. Evaluate if your packaged devices meet the definition of a convenience kit according to the guidance criteria
  2. Ensure proper UDI labeling on the convenience kit package
  3. Document justification for convenience kit classification
  4. Submit required data to GUDID for the convenience kit
  5. Implement process for assigning new DIs when making changes to the kit
  6. Consider including DIs of individual devices in the GUDID record if individual UDIs are used
  7. Ensure compliance with direct marking requirements for any reusable devices within the kit
  8. Establish procedures to maintain UDI compliance throughout the product lifecycle
  9. Consider requesting exceptions or alternatives if needed under 21 CFR 801.55

Key Considerations

Labelling

  • The label and device package of a convenience kit must bear a UDI
  • Individual devices within a convenience kit are excepted from UDI labeling requirements if the convenience kit label bears a UDI
  • Production identifiers (PIs) must be included in the convenience kit UDI as required by 21 CFR 801.40(b)

Other considerations

  • 21 CFR 801.3: Definitions
  • 21 CFR 801.20: Label to bear a unique device identifier
  • 21 CFR 801.30: Exceptions from UDI labeling requirements
  • 21 CFR 801.40: Form of a unique device identifier
  • 21 CFR 801.45: Direct marking requirements

Original guidance

  • Unique Device Identification Requirements for Convenience Kits
  • HTML / PDF
  • Issue date: 2019-04-26
  • Last changed date: 2021-07-15
  • Status: FINAL
  • Official FDA topics: Medical Devices, UDI, Labeling, Biologics
  • ReguVirta summary file ID: 3e77aa97d4bf71a044be3868aecc35ba
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